Diastolic Dysfunction Clinical Trial
Official title:
Effects of Levosimendan on Systolic Deformation and Diastolic Function in Patients Eligible for Aortic Valve Replacement With Left Ventricular Hypertrophy
This is a clinical, randomised, double-blinded study in which patients eligible for aortic valve replacement are enrolled. Patients receive infusion of either levosimendan or placebo 4 hours prior to surgery and until the end of surgery.
Levosimendan or placebo will be infusion for approximately 4 hours prior to aortic valve
replacement in patients with severe hypertrophy of the left ventricle and echocardiographic
signs of diastolic dysfunction. Outcome measures will be obtained at some of the following:
- Approximately 4 hours prior to surgery. Baseline. Start of levosimendan/placebo infusion
- Immediately before surgery
- After induction of anaesthesia and before "knife time" = start of surgery.
- At the end of surgery: Levosimendan infusion will stop.
- Approximately 4 hours after surgery immediately before extubation.
- Approximately 21 hours after surgery
- Approximately 96 hours after surgery (day 4)
- 6 months after surgery
Outcome measures are comprised of invasive measurements, blood samples, transthoracic
echocardiography and transoesophageal echocardiography focusing on measures of systolic and
diastolic function of the heart.
Interim analysis will be conducted after 30 included patients.
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